Biodex Medical Systems, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.Class IIAug 16, 2021When deleting a previously entered custom isotope, the softw	When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated di	Class IIDevices	Aug 16, 2021
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332Class IIAug 16, 2021When deleting a previously entered custom isotope, the softw	When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated di	Class IIDevices	Aug 16, 2021